3 July 2012

“ICH Parties Agree on New Principles of Governance”

The International Conference on Harmonisation (ICH) Steering Committee (SC) and its Expert Working Groups (EWGs) met in Fukuoka, Japan on June 2-7, 2012. Building on 20 years of successful collaboration towards achieving greater international harmonisation for pharmaceutical products registration, the ICH parties agreed on new principles of governance for robust science-based Guidelines for the review of the safety, efficacy, and quality of medicinal products. In addition, ICH confirmed its commitment to strengthen its global outreach. Further progress was made on the individual topics, notably the Electronic Common Technical Document (eCTD) (ICH M8).

New Principles of Governance
The six official ICH parties have agreed on new principles of governance which better define the roles of regulator and industry parties within ICH. This action will highlight ICH’s longstanding premise that the regulators have the ultimate responsibility in ensuring the protection of public health, in addition to their competence to issue regulatory Guidelines.

ICH will continue to be consensus driven, and strive to remain at the cutting-edge of scientific and technical developments in the pharmaceutical area. This will require the continued close cooperation between regulatory and pharmaceutical industry experts that has been instrumental in providing the best scientific and technical input in the development of ICH products, but with some changes. In the future, EWGs will be chaired by a representative of the regulators who will be responsible for ensuring regulatory oversight as well as integrity of the entire process. In addition, the current four step ICH procedure for work products will be reviewed to provide a clear distinction between the collation of scientific and technical information into a "technical document" by the experts, and the development of this document into a regulatory ICH Guideline by the regulators.

In circumstances when regulators and industry may not have the same interests or priorities with respect to a particular harmonisation activity the new principles allow ICH to proceed with a proposed topic for harmonisation provided it is supported by the three ICH regulatory parties, irrespective of whether or not this topic is supported by the industry parties.

The current Step 3 procedures of public consultation within the three regulatory parties, as well as through ICH, Observers and WHO contact points, will be maintained. Transparency will be further increased through the publication of information about the ICH process on the ICH website, including publication of "technical documents." These principles will be incorporated into revised Rules of Procedures which are due to be adopted at the next meeting of the ICH Steering Committee.

Global Outreach Activities
The ICH Steering Committee and the Global Cooperation Group (GCG)1 welcomed an increased commitment from the Regional Harmonisation Initiatives (RHIs) and Drug Regulatory Authorities that constitute the GCG. The regulators from beyond the original three ICH regions and the RHIs voiced strong support for regular dialogue amongst themselves and to further contribute to the GCG and related activities.

Multidisciplinary Update
The M8 EWG/IWG “Electronic Common Technical Document (eCTD)” has progressed the eCTD v4.0 Draft Implementation Guide (IG) to the feasibility testing towards Step 2. During this period, the usability of the Draft IG along with technical feasibility of HL7 Regulated Product Submissions (RPS) standard to the ICH requirements will be tested. The M8 IWG has released the updated Q&A on the current eCTD specifications which gives further guidance on organization of CTD Module 3 documents by XML attributes.

Safety Update
The S1 EWG “Rodent Carcinogenicity Studies for Human Pharmaceuticals” met for the first time. This working group will clarify the criteria used to determine, without compromising safety, the necessity of two-year rodent carcinogenicity studies to address the risk of human carcinogenicity in pharmaceuticals under development.

Efficacy Update
The Q&As on the E3 Guideline “Structure and Content of Clinical Study Reports (CSR)” reached Step 4. This document clarifies several important aspects in documenting the CSRs, including flexibility in the structure, requirements for appendices, and terminologies used in the E3 Guideline.

Quality Update
The Annex 13 “Bulk Density and Tapped Density of Powders General Chapter” to the Q4B Guideline reached Step 4. This harmonisation of pharmacopoeial texts in the three regions will reduce testing requirements for the industry. FAQs on the Q4B concept and activities will also be available on the ICH website.

The next ICH Steering Committee and its expert working groups meetings will be held in San Diego, California, USA, on November 10-15, 2012.

For further information, please contact:
ICH Secretariat
Chemin Louis-Dunant, 15
P.O Box 195, 1211 Geneva 20
Tel: +41 22 338 3206 - Fax: +41 22 338 3230
E-mail: admin@ich.org - Web site: www.ich.org

1The ICH Global Cooperation Group is a subgroup of the ICH Steering Committee and is composed of one representative from each of the six parties on the ICH Steering Committee, plus three Observers (WHO, Health Canada and EFTA) and IFPMA are also part of the GCG. Regional Harmonisation Initiatives, namely APEC, ASEAN, EAC, GCC, PANDRH and SADC, as well as Drug Regulatory Authorities and Departments of Health from Australia, Brazil, China, Chinese Taipei, India, Republic of Korea, Russia and Singapore have also been invited to designate permanent representatives to the GCG.

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